510(k) Report

Devices descending from K050461

742 later devices reach Xia 4.5 Spinal System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+8K231483MySpine Unilateral GuidesMedacta International S.A.20230—
+8K223301ASTRA & AVANT Navigation Instruments System and ASTRA-OCT Navigation Instruments SystemSpinecraft, LLC20230—
+8K231839CastleLoc-P Anterior Cervical Plate System, AccelFix Lumbar Plate SystemL&K BIOMED Co., Ltd.20232—
+8K230721ATEC Lateral Plate SystemAlphatec Spine, Inc.20230—
+8K222097OLYMPIC Deformity Band SystemAstura Medical20233—
+8K223708Entasis 3D Dual-Lead Sacroiliac Implant SystemCorelink, LLC20233—
+8K230063G Surgical Marksman Spinal Deformity SystemG Surgical, LLC20230—
+8K222774iFuse Bedrock Granite® Implant SystemSI-BONE, Inc.202220—
+8K223294SpineJack® Expansion KitStryker Instruments20221—
+8K223070Remi Robotic Navigation SystemFusion Robotics, LLC20224—
+8K222270HEDRON Cervical Spacers, HEDRON Lumbar Spacers, SABLE Expandable Spacer, ExcelsiusGPS…Globus Medical, Inc.202223—
+8K222698CUVIS-spineCurexo, Inc.20220—
+8K221821ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20221—
+8K221332OsteoCentric Spine MIS Pedicle Fastener SystemOsteoCentric Technologies20221—
+8K221905INERTIA CONNEXX Modular Pedicle Screw SystemNexxt Spine, LLC20221—
+8K221244CD Horizon™ Spinal SystemMedtronic202220—
+8K213491Universal Pilot Guidance Instrument SystemCtl Medical Corporation20220—
+8K220038Camber Spine Navigation SystemCamber Spine Technologies20220—
+8K212962TRELLIS™ SI Joint Fusion SystemOrthofundamentals, LLC20220—
+8K212489BonOs Inject Bone Cement; NEO Pedicle Screw SystemNeo Medical SA20215—
+8K203607MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20210—
+8K202836GX Navigation Instrument SystemLife Spine, Inc.20211—
+8K212066Adena-Zina SystemShanghai Sanyou Medical Co, Ltd.20213—
+8K210716CarboClear X Pedicle Screw System, CarboClear X Navigated InstrumentsCarboFix Orthopedics, Ltd.20218—
+8K203673MySpine Pedicle Screw Placement Guides Extension (MySpine Low Profile Guides, MySpine MC…Medacta International S.A.20213—
+8K203452Nano FortiFix® SystemNanovis, LLC20200—
+8K203125Invictus™ OCT Spinal Fixation SystemAlphatec Spine, Inc.20200—
+8K203317CarboClear X Pedicle Screw SystemCarboFix Orthopedics, Ltd.20209—
+8K201427Trivergent Spinal Fixation SystemBenvenue Medical, Inc.20202—
+8K200596G21 Cement, VADER® Pedicle SystemIcotec AG2020271
+8K200792MySpine S2-Alar/Alar-Iliac Pedicle Screw Placement GuidesMedacta Inernational SA20204—
+8K201251CarboClear Navigated InstrumentsCarboFix Orthopedics, Ltd.20209—
+8K193423VADER®one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG202061
+8K200936Invictus™ CT Spinal Fixation SystemAlphatec Spine, Inc.20203—
+8K200303Reform Pedicle Screw SystemPrecision Spine202010—
+8K200519CarboClear® II Pedicle Screw SystemCarboFix Orthopedics, Ltd.202011—
+8K200070ARx Spinal SystemLife Spine, Inc.20209—
+8K193270CapLOX II®/TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20200—
+8K192938Invictus™ Spinal Fixation SystemAlphatec Spine, Inc.201969—
+8K191722Vital Navigation SystemZimmer Biomet Spine, Inc.20192—
+8K192281AEGIS Anterior Lumbar Plate System, ALC Dynamized Fixation System, Anterior ISOLA Spine…Medos International SARL20190—
+8K191854Premia Spine XL InstrumentsPremia Spine, Ltd.20190—
+8K191835CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.20192—
+8K190163ALARA Neuro Access KitSurGenTec, LLC20192—
+8K190545VADER® one Pedicle System MIS and LightMore® Pedicle System 6.0Icotec AG2019291
+8K182416NOVA Minimally Invasive SystemBaui Biotech Co., Ltd.20192—
+8K182617ATEC IOM Accessory InstrumentsAlphatec Spine, Inc.20193—
+8K183430Modular Spinal Fixation SystemLife Spine, Inc.20192—
+8K182771ISS-JAZZ Screw System and JAZZ CAP SPImplanet, S.A.20195—
+8K182478Whistler Modular Pedicle Screw SystemEvolution Spine, LLC20196—
+8K182954Salvo™ Spine SystemSpine Wave, Inc.20186—
+8K180980ORTHROS™ Posterior Stabilization System; ORTHROS™ MIS Posterior Stabilization SystemCamber Spine Technologies, LLC20181—
+8K182377CarboClear® Pedicle Screw SystemCarboFix Orthopedics, Ltd.201839—
+8K181821MOSS VRS Spinal SystemBiedermann Motech GmbH & Co. KG20181—
+8K180179Firebird® Spinal Fixation Systems: Firebird System; Firebird Deformity System; Firebird®…Orthofix, Inc.201837—
+8K181978Zenius™, Iliad™ and Kora™ Spinal Fixation SystemsMedyssey USA, Inc.20180—
+8K181677Kodiak Spinal Fixation SystemAlphatec Spine, Inc.201870—
+8K181281Altus Spine Pedicle Screw SystemAltus Partners, LLC20181—
+8K180475CapLOX II® / TowerLOX® MIS Pedicle Screw SystemCaptiva Spine, Inc.20180—
+8K171421VERTICALE® Posterior Spinal Fixation System/VERTICALE® SystemSilony Medical GmbH20186—
+8K173130Reform® Midline Cortical Screw SystemPrecision Spine, Inc.201721—
+8K172469TiLock Modular Spinal SystemGenesys Spine20170—
+8K172417SILC® Fixation SystemGlobus Medical, Inc.20171—
+8K171321K2M Navigation InstrumentsK2m201711
+8K172194Connector SystemOrthofix, Inc.2017162
+8K161225Paonan Armstrong Posterior Spinal Fixation SystemPaonan Biotech Co., Ltd.20172—
+8K171907Vitality® Spinal Fixation SystemZimmer Biomet Spine, Inc.2017162
+8K170964Zenius Spinal SystemMedyssey USA, Inc.20170—
+8K170266Palisade™ Pedicular Fixation SystemSpineology, Inc.20172—
+8K170255Threshold™ V2 Pedicular Fixation SystemSpineology, Inc.20171—
+8K170251Threshold™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K170268Fortress™ Pedicular Fixation SystemSpineology, Inc.20171—
+8K162921Navigated Instrument SystemOrthofix, Inc.20175—
+8K162419FIREFLY® Pedicle Screw Navigation GuideMighty Oak Medical, Inc.20167—
+8K161014NuVasive® Reline® SystemNu Vasive, Incorporated201648—
+8K161387Mont Blanc and Mont Blanc MIS Spinal SystemsSpineway SA20163—
+8K161369EVEREST Spinal SystemK2m, Incorporated20169—
+8K160226JAZZ CLAW System (hooks and rods) and JAZZ CLAW connectorImplanet, S.A.20161—
+8K153404Zavation Spinal SystemZavation, LLC20161—
+8K151977icotec Pedicle SystemIcotec AG201630—
+8K151116CapLOX II/TowerLOX Pedicle Screw SystemCaptiva Spine20153—
+8K142835Iliad Pedicle Screw System and Zenius Pedicle Screw SystemMedyssey USA, Inc.20155—
+8K150552ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMSGlobus Medical, Inc.2015961
+8K143633CREO Stabilization SystemGlobus Medical, Inc.2015158—
+8K143334Range/Denali/Mesa Spinal SystemK2m, Inc.201516—
+8K142146Ibis Pedicle Screw SystemOrtho Development Corp.20145—
+8K141850Flospine Pedicle Screw SystemFlospine20140—
+8K133402K2M Modular HooksK2m, Inc.20140—
+8K133366Orthros Posterior Stabilization SystemCamber Spine20142—
+8K131785Pagoda Pedicle Screw SystemOrtho Development Corp.20136—
+8K121786Dymaxeon Spine SystemB2b Spine Pty, Ltd.20125—
+9K261113Op.n™ Spine Navigation and Robotic GuidanceEcential Robotics20261—
+9K253216IntraOp Alignment System; CONTOUR3D Bending SystemAlphatec Spine, Inc.20260—
+9K253045“Socko” Vimax Spinal Fixation SystemSocko Medical Co., Ltd.20260—
+9K251251ChanPin Pedicle Screw Spinal SystemChanpin Medtak Co., Ltd.20260—
+9K260571SIMPACT Sacroiliac Joint Fixation System GX Navigation InstrumentsLife Spine, Inc.20260—
+9K261112CastleLoc-P Anterior Cervical Plate SystemL&K BIOMED Co., Ltd.20260—
+9K253401SCRIPT™ Implant SystemGlobus Medical, Inc.20260—
+9K260216CD Horizon™ ModuLeX™ Fenestrated Screw Set; CD Horizon™ ModuLeX™ Spinal SystemMedtronic Sofamor Danek USA, Inc.20260—
+9K251940PathLoc Lumbar Plate SystemL&K BIOMED Co., Ltd.20260—